Study in Parkinson's Disease of Exercise (SPARX)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: Vigorous Exercise; Behavioral: No Intervention; Behavioral: Moderate Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01506479

R01NS074343 (U.S. NIH Grant/Contract)

11-1237

Details and patient eligibility

About

The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit.

Full description

The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.

Enrollment: 128 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of primary Parkinson's disease
• In a Hoehn and Yahr stage less than stage III
• Disease duration is less than 5 years
• Not likely to require dopaminergic therapy within 6 months

Exclusion criteria

• Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
• Duration of previous use of medications for PD that exceeds 90 days
• Expected to require dopaminergic therapy in the next 6 months
• Poorly controlled or unstable cardiovascular disease
• Uncontrolled hypertension
• Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function
• Mild cognitive impairment (Montreal Cognitive Assessment score<26/30)
• Depression that precludes ability to exercise (Beck depression score>13)
• Disorders that interfere with ability to perform endurance exercises
• Regular participation in vigorous endurance exercise
• Evidence of serious arrhythmias or ischemic heart disease
• Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 3 patient groups

Control Group

Sham Comparator group

Description:

Wait listed to moderate or vigorous exercise after 6 months of no exercise.

Treatment:

Behavioral: No Intervention

Vigorous Exercise

Experimental group

Description:

Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

Treatment:

Behavioral: Vigorous Exercise

Moderate Exercise

Experimental group

Description:

Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

Treatment:

Behavioral: Moderate Exercise